Clinical Researcher—February 2023 (Volume 37, Issue 1)

ON THE JOB

Limaris Alvarado, MSME

 

It is no secret that employees are the heart of any business. It is, therefore, important that they remain engaged so that they can continuously provide high-quality work. Even though this is true in any business sector, it is particularly important for companies in the life sciences industry, where personnel must deal with many complex processes in a highly regulated environment to ensure both product and operations are compliant.

But what must life sciences company leaders do to make sure their staff are engaged? While there are many aspects to be considered, one that takes this goal a long way is having an effective training program. This cannot be just any training program, rather one that is linked to the goals of your organization.

There are several reasons why effective training programs are key. First, every organization in a regulated industry must train its employees, as is required by all major regulatory bodies around the world. Second, training helps with developing or refining the knowledge and skills of the personnel so that they can safely, effectively, and consistently perform their jobs. This, in turn, is proven to boost their engagement levels while attaining a quality culture throughout your organization.

Moreover, enhancing the knowledge and skills of employees naturally increases their abilities for future delivery. Consequently, establishing a training program linked to the organization goals will provide you with well-trained, proficient, and engaged employees who will be able to speak knowledgeably about the industry, and will greatly contribute to increasing customer satisfaction levels.

What is Employee Training?

At its core, training is teaching, or developing any skills and knowledge that relate to specific competencies. Employee training provides workers with education and skills related to their jobs and areas of expertise to assist them in staying up to date with the skills that are needed and in demand from the job market they belong to.

When dealing with a regulated environment such as that found in the life sciences industry, the expectations from regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada are clear. Regulations from these agencies set out requirements for education and training, as well as the number of personnel needed to perform required tasks and duties. Some common expectations outlined in regulations are:

• “Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.”{1}
• Tasks, roles, and responsibilities are defined in job descriptions and organization charts.
• Personnel are trained and/or otherwise qualified in the procedures and methods they use and the tasks they perform.
• Key personnel—including consultants and contractors—have the professional, educational, and experiential credentials required.
• Supervisors and management have training that is appropriate to their functions.

The takeaways here are simple but critical: regulatory investigators are looking for assurance that personnel have the qualifications and skill sets required to perform tasks and fulfill their duties. Given these expectations, every individual must be educated and qualified (and re-trained or re-qualified, as needed) to perform the specific tasks they are assigned.

Developing an Employee Training Program Linked to the Organization’s Goals

There are some valuable steps that organizational leaders can take to ensure their employees are not just trained to the requirements, but also to the goals and objectives of the organization:

1. Identify Your Needs and Establish Goals

Be clear from the outset what the organization is trying to achieve (goals, objectives, and mission statements). This is important for a very practical reason: you want to invest your money wisely. This first analysis will identify job-related tasks that must be learned, next steps, and strategies to achieve the goals, competencies, and skills required to perform the job. It will also identify the employees who need training. For example, you might identify the need to strengthen the technical side (products/processes) of your sales team, so they can add new elements into their sales pitches. This step should help with that determination.

2. Turn Internal Subject Matter Experts into Training Partners

These resources are critical as they are the content experts. They can contribute to the design of the training program by ensuring the course content is focused on the learner’s needs. They will also help ensure that courses are effective and meet business objectives.

3. Assess the Current State of Training

The assessment should cover:

• Organizational skills: Do the people in your organization have the knowledge and abilities required to achieve your organization’s strategic objectives?
• Occupational skills: Do employees possess the knowledge, skills, and abilities required to do their day-to-day jobs?
• Individual assessment: How is each employee performing? What are their required training needs

4. Identify Strengths and Gaps

The assessment should identify who needs training and the type of training needed to bridge gaps and enhance company performance. The following questions may be used as a starting point:

• What is the organization trying to accomplish?
• What skills are needed for organizational success?
• What is the current skill level of each employee?
  

5. Track, Analyze, and Improve

Once started, the training must be executed continuously to achieve full benefits. Training should not be a one-off event, otherwise, the benefits may be short-lived. You need to also keep in mind that everybody learns differently, and what works for some individuals may not work for others. Therefore, it is extremely important to track and measure the results and strive for an individualized approach (or focus) when needed.

Another important aspect is being able to deliver training at the right time. If there is a training need or the need to improve the knowledge or skill set of a team from a particular area, it is important to address it with the right training at the right time. One example would be the onboarding training that every new employee is expected to receive. It must be done immediately to equip the new employees with the required tools to execute appropriately right away.

Having a competent, professional workforce is essential to meeting the dual goals of business requirements and regulatory expectations. With an effective training program that is linked to your organization’s goals, you can efficiently accomplish both, and increase employee’s engagement levels as a result.

Reference

1. U.S. Food and Drug Administration. Code of Federal Regulations Title 21 (21 CFR 211.25). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=211.25

Limaris Alvarado, MSME, leads the Quality Management and Compliance division of PharmaLex US. She has more than 25 years of experience working for various biopharmaceutical companies and has been responsible for multiple product introductions or transfers and launches (from development to commercial and from manufacturing “sister site” into commercial site) achieving successful consecutive prior-approval and routine inspections.